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临床试验/NCT04867694
NCT04867694已完成不适用

Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad

International Food Policy Research Institute1 个研究点 分布在 1 个国家目标入组 2,089 人开始时间: 2021年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,089
试验地点
1
主要终点
Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).

研究概览

简要总结

The IRAM Chad impact evaluation will be based on a cluster randomized controlled trial to study the impact of the integrated and multisectoral services package (PASIM), aimed at reducing the incidence and prevalence of wasting through integrated interventions, including, among other things, strengthening the activity of community care groups, food supplementation, water treatment, and screening for wasting conducted by families.

详细描述

The general objective of the integrated and multisectoral services package (PASIM) is to reduce the incidence and prevalence of wasting through integrated interventions, including, among other things, strengthening the activity of community care groups. The members of the care groups conduct home visits to children aged 6-23 months (or up to 59 months when the children are under treatment for wasting or have been discharged in the previous 6 months) to deliver messages for behavioral change related to complementary feeding, health and hygiene ; deliver nutritional supplement and water purification inputs; improve screening coverage (training and supervision of families to take the Mid-Upper Arm Circumference measurements, referral of malnourished cases); and verify adherence to treatment of malnourished cases, in the health district of Mongo, Guéra province, Chad, Central Africa.

The evaluation of the impact of PASIM will be based on a cluster randomized controlled trial, consisting of 100 villages or clusters of villages. The selected evaluation model will be that of a comparison of control groups (n=50; no implementation of the intervention) and intervention (n=50) through the follow-up of 3 cohorts :

  1. Longitudinal in-home follow-up of a semi-open cohort of 1,750 children aged 6 months at enrollment (included continuously for 7 months and all followed through to the end of the study, which will last 9 months in total).
  2. Longitudinal follow-up of all children aged 6-23 months enrolled for wasting treatment, based on health system records.
  3. Longitudinal follow-up at home for 6 months of a closed cohort of 700 children aged 6-23 months at inclusion, discharged from a treatment for acute malnutrition.

The primary impact results are as follows:

  • The longitudinal prevalence of wasting at the end of the study (Cohort 1).
  • The recovery rate (Cohort 2).
  • The incidence of relapse during the 11 months of the intervention (Cohort 3).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Months 至 23 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).

时间窗: Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first

This indicator is defined for each child as the number of visits during which wasting is observed divided by the total number of monthly visits made (by interviewers).

Recovery rate in children enrolled at [6-23] months of age for up to 3 months of treatment and followed through to discharge (Cohort 2).

时间窗: Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first

This indicator is defined as the number of discharges considered cured according to national program criteria (WHZ\>-2 and MUAC\>=125mm and absence of bilateral edema for two consecutive visits, within 12 weeks of enrollment in the program) divided by the total number of exits recorded.

Incidence of wasting in children enrolled at [6-23] months of age at discharge from a CMAM program cured, and followed for 6 months (Cohort 3).

时间窗: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first

This indicator is defined as the number of new cases of wasting recorded during monthly visits.

次要结局

  • Longitudinal wasting screening coverage (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Incidence of wasting, MAM and SAM (cohort 1)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Incidence of MAM and SAM (cohort 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Longitudinal prevalence of MAM (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • MUAC gain (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Longitudinal prevalence of SAM (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • prevalence of anemia (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression)
  • Speed of weight growth (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • longitudinal prevalence of childhood morbidity, i.e. acute respiratory infections, fever, diarrhea and malaria (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • MUAC at enrollment in CMAM (cohort 2)(at the date of inclusion in CMAM program)
  • Treatment adherence (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first)
  • Prevalence of stunting (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Parental knowledge of nutrition, WASH, and health best practices (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Vaccination coverage (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Mean hemoglobin concentration (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression)
  • Height-for-age Z-score (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Referral rate of positive screenings (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Enrollment of wasting, MAM, and SAM cases (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Linear growth rate (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Weight gain (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Longitudinal prevalence of minimum dietary diversity of infant and young children (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Longitudinal prevalence of minimum meal frequency (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Practices related to water, hygiene and sanitation (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • weight-for-height in z-score at enrollment in CMAM (cohort 2)(at the date of inclusion in CMAM program)
  • Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first)
  • Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
  • Duration of CMAM treatment (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first)
  • longitudinal prevalence of childhood morbidity (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elodie Becquey

Senior Research Fellow

International Food Policy Research Institute

研究点 (1)

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